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An enriched-enrolment, randomized withdrawal, flexible-dose, double-blind, placebo-controlled, parallel assignment efficacy study of nabilone as adjuvant in the treatment of diabetic peripheral neuropathic pain.

Abstract

Cannabinoids are emerging as potential options for neuropathic pain treatment. This study evaluated an oral cannabinoid, nabilone, in the treatment of refractory human diabetic peripheral neuropathic pain (DPN). We performed a single-center, randomized, double-blind, placebo-controlled, flexible-dose study with an enriched enrollment randomized withdrawal design. DPN subjects with a pain score ≥ 4 (0-10 scale) continued regular pain medications and were administered single-blinded adjuvant nabilone for 4 weeks. Subjects achieving ≥ 30% pain relief (26/37) were then randomized and treated with either flexible-dose nabilone 1-4 mg/day (n=13) or placebo (n=13) in a further 5-week double-blind treatment period, with 30% (11/37) of subjects deemed run-in-phase nabilone nonresponders. For nabilone run-in-phase responders, there was an improvement in the change in mean end-point neuropathic pain vs placebo (mean treatment reduction of 1.27; 95% confidence interval 2.29-0.25, P=0.02), with an average nabilone dose at end point of 2.9 ± 1.1mg/day, and improvements from baseline for the anxiety subscale of the Hospital Anxiety and Depression Scale, the Medical Outcomes Study sleep scale problems index, and the European Quality of Life-5-Domains index score (each P<0.05). Nabilone run-in-phase responders reported greater global end-point improvement with nabilone than with placebo (100% vs 31%; P<0.05). Medication-related confusion led to discontinuation in 2/37 subjects during single-blind nabilone treatment. Potential unmasking occurred in 62% of both groups. Flexible-dose nabilone 1-4 mg/day was effective in relieving DPN symptoms, improving disturbed sleep, quality of life, and overall patient status. Nabilone was well tolerated and successful as adjuvant in patients with DPN.

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  • Authors+Show Affiliations

    ,

    The Department of Clinical Neurosciences, the Hotchkiss Brain Institute, and the University of Calgary, Calgary, Alberta, Canada. corytoth@shaw.ca

    , , , , , , ,

    Source

    Pain 153:10 2012 Oct pg 2073-82

    MeSH

    Adolescent
    Adult
    Aged
    Aged, 80 and over
    Analgesics
    Chemotherapy, Adjuvant
    Diabetic Neuropathies
    Dose-Response Relationship, Drug
    Double-Blind Method
    Dronabinol
    Female
    Humans
    Male
    Middle Aged
    Neuralgia
    Placebo Effect
    Treatment Outcome
    Young Adult

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    22921260

    Citation

    Toth, Cory, et al. "An Enriched-enrolment, Randomized Withdrawal, Flexible-dose, Double-blind, Placebo-controlled, Parallel Assignment Efficacy Study of Nabilone as Adjuvant in the Treatment of Diabetic Peripheral Neuropathic Pain." Pain, vol. 153, no. 10, 2012, pp. 2073-82.
    Toth C, Mawani S, Brady S, et al. An enriched-enrolment, randomized withdrawal, flexible-dose, double-blind, placebo-controlled, parallel assignment efficacy study of nabilone as adjuvant in the treatment of diabetic peripheral neuropathic pain. Pain. 2012;153(10):2073-82.
    Toth, C., Mawani, S., Brady, S., Chan, C., Liu, C., Mehina, E., ... Korngut, L. (2012). An enriched-enrolment, randomized withdrawal, flexible-dose, double-blind, placebo-controlled, parallel assignment efficacy study of nabilone as adjuvant in the treatment of diabetic peripheral neuropathic pain. Pain, 153(10), pp. 2073-82. doi:10.1016/j.pain.2012.06.024.
    Toth C, et al. An Enriched-enrolment, Randomized Withdrawal, Flexible-dose, Double-blind, Placebo-controlled, Parallel Assignment Efficacy Study of Nabilone as Adjuvant in the Treatment of Diabetic Peripheral Neuropathic Pain. Pain. 2012;153(10):2073-82. PubMed PMID: 22921260.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - An enriched-enrolment, randomized withdrawal, flexible-dose, double-blind, placebo-controlled, parallel assignment efficacy study of nabilone as adjuvant in the treatment of diabetic peripheral neuropathic pain. AU - Toth,Cory, AU - Mawani,Shefina, AU - Brady,Shauna, AU - Chan,Cynthia, AU - Liu,CaiXia, AU - Mehina,Essie, AU - Garven,Alexandra, AU - Bestard,Jennifer, AU - Korngut,Lawrence, Y1 - 2012/08/23/ PY - 2011/11/30/received PY - 2012/06/06/revised PY - 2012/06/20/accepted PY - 2012/8/28/entrez PY - 2012/8/28/pubmed PY - 2013/3/7/medline SP - 2073 EP - 82 JF - Pain JO - Pain VL - 153 IS - 10 N2 - Cannabinoids are emerging as potential options for neuropathic pain treatment. This study evaluated an oral cannabinoid, nabilone, in the treatment of refractory human diabetic peripheral neuropathic pain (DPN). We performed a single-center, randomized, double-blind, placebo-controlled, flexible-dose study with an enriched enrollment randomized withdrawal design. DPN subjects with a pain score ≥ 4 (0-10 scale) continued regular pain medications and were administered single-blinded adjuvant nabilone for 4 weeks. Subjects achieving ≥ 30% pain relief (26/37) were then randomized and treated with either flexible-dose nabilone 1-4 mg/day (n=13) or placebo (n=13) in a further 5-week double-blind treatment period, with 30% (11/37) of subjects deemed run-in-phase nabilone nonresponders. For nabilone run-in-phase responders, there was an improvement in the change in mean end-point neuropathic pain vs placebo (mean treatment reduction of 1.27; 95% confidence interval 2.29-0.25, P=0.02), with an average nabilone dose at end point of 2.9 ± 1.1mg/day, and improvements from baseline for the anxiety subscale of the Hospital Anxiety and Depression Scale, the Medical Outcomes Study sleep scale problems index, and the European Quality of Life-5-Domains index score (each P<0.05). Nabilone run-in-phase responders reported greater global end-point improvement with nabilone than with placebo (100% vs 31%; P<0.05). Medication-related confusion led to discontinuation in 2/37 subjects during single-blind nabilone treatment. Potential unmasking occurred in 62% of both groups. Flexible-dose nabilone 1-4 mg/day was effective in relieving DPN symptoms, improving disturbed sleep, quality of life, and overall patient status. Nabilone was well tolerated and successful as adjuvant in patients with DPN. SN - 1872-6623 UR - https://www.unboundmedicine.com/medline/citation/22921260/An_enriched_enrolment_randomized_withdrawal_flexible_dose_double_blind_placebo_controlled_parallel_assignment_efficacy_study_of_nabilone_as_adjuvant_in_the_treatment_of_diabetic_peripheral_neuropathic_pain_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0304-3959(12)00400-9 DB - PRIME DP - Unbound Medicine ER -